First author [ref.] | Year | Patients randomised | Treatment and duration | Decline in lung density at TLC | Difference |
Dirksen [13] | 1999 | 28 AAT and 28 placebo | 250 mg·kg−1 AAT every 4 weeks for 3 years | Annual change: AAT −1.5 (sd 0.41) g·L−1; placebo: −2.57 (sd 0.41) g·L−1 | 1.07 (sd 0.58) g·L−1 per year (p=0.07) |
Dirksen [14] | 2009 | 36 AAT and 35 placebo | 60 mg·kg−1 AAT every week for 2 years | Total change (2 years)#: AAT −2.36– −3.38 g·L−1; placebo −3.81– −4.82 g·L−1 | Total difference (2 years)#: 1.47–1.59 g·L−1 (p values between 0.084 and 0.049#) |
Stockley [18] | 2010 | Pooled analysis of previous RCTs. 60 AAT and 59 placebo | 250 mg·kg−1 or 60 mg·kg−1 of AAT every 4 weeks or every week | Total change (2 years): AAT: −4.08 g·L−1; placebo: −6.38 g·L−1 | Total difference (2 years): 2.29 g·L−1 (p=0.006) |
Chapman [15] | 2015 | 93 AAT and 87 placebo | 60 mg·kg−1 of AAT every week for 2 years | Annual change: AAT −1.45 (se 0.23) g·L−1; placebo −2.19 (se 0.25) g·L−1 | 0.74 g·L−1 (p=0.03) |
#According to the four different adjustments for evaluation of lung density performed in the study. TLC: total lung capacity; AAT: α1-antitrypsin; RCT: randomised controlled trial; AT: augmentation therapy; sd: standard deviation; se: standard error.